Photo: David Cheskin - PA Images/Getty Images

The Food and Drug Administration (FDA) approved a fast-acting nasal treatment for depression Tuesday to be marketed under the name Spravato, intended to help adults who live with severe depression that have not responded to other treatments.

Why it matters: Nearly 16 million American adults are currently diagnosed with depression, of which as many as 5 million fail to respond to existing treatments, reports the Washington Post. The new drug, developed by Janssen Pharmaceuticals Inc., an arm of Johnson & Johnson, comes in the form of a nasal spray called esketamine and can be effective within hours, rather than the weeks or months typical of other antidepressants, such as Prozac.

Details: The FDA approval requires that doses be given in certified settings such as a doctor's office or clinic, and that patients be monitored for at least 2 hours in case of side effects, such as disassociation. In addition, the packaging for the new treatment will contain a so-called "black box" warning label — the most serious category — indicating potential sedation, problems with attention, judgment and thinking, as well as abuse and suicidal thoughts.

But, but, but: The drug, which contains an active form of ketamine, has antidepressant properties that are not entirely understood, particularly when it comes to its long-term effects, Jeffrey Lieberman, a Columbia University psychiatrist told the Post.

The bottom line: Esketamine represents the first depression drug in years to be approved that works via a completely different mechanism in the brain, as compared to the previous generation of medications. For many with treatment-resistant depression, the new drug offers newfound hope of relief.

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Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Global: Total confirmed cases as of 4:30 p.m. ET: 21,020,216 — Total deaths: 761,393— Total recoveries: 13,048,303Map.
  2. U.S.: Total confirmed cases as of 4:30 p.m. ET: 5,289,323 — Total deaths: 167,948 — Total recoveries: 1,774,648 — Total tests: 64,831,306Map.
  3. Health: CDC: Survivors of COVID-19 have up to three months of immunity Fauci believes normalcy will return by "the end of 2021" with vaccine — The pandemic's toll on mental health.
  4. Business: How small businesses got stiffed — Unemployment starts moving in the right direction.
  5. Cities: Coronavirus pandemic dims NYC's annual 9/11 Tribute in Light.
  6. Politics: Biden signals fall strategy with new ads.

Harris: "Women are going to be a priority" in Biden administration

Sen. Kamala Harris at an event in Wilmington, Del. Photo: Drew Angerer/Getty Images

In her first sit-down interview since being named Joe Biden's running mate, Sen. Kamala Harris talked about what she'll do to fight for women if elected VP, and how the Democrats are thinking about voter turnout strategies ahead of November.

What they're saying: "In a Biden-Harris administration women are going to be a priority, understanding that women have many priorities and all of them must be acknowledged," Harris told The 19th*'s Errin Haines-Whack.

Facebook goes after Apple

Illustration: Lazaro Gamio/Axios

Facebook is seeking to force a face-off with Apple over its 30% in-app purchase commission fee, which Facebook suggests hurts small businesses struggling to get by during the pandemic.

The big picture: Facebook has never publicly gone after Apple, a key strategic partner, this aggressively. Both companies face antitrust scrutiny, which in Apple's case has centered on the very fee structure Facebook is now attacking.